DESFERRIOXAMINE MESILATE 500 MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION
Active substance(s): DEFEROXAMINE MESILATE
Package leaflet: Information for the user
Desferrioxamine Mesilate 500 mg & 2g Powder for Solution for Injection or Infusion
Read all of this leaflet carefully before you start using this medicine because it contains
important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
The name of your medicine is the following:
Desferrioxamine Mesilate 500 mg Powder for Solution for Injection or Infusion
Desferrioxamine Mesilate 2 g Powder for Solution for Injection or Infusion
In the rest of this leaflet your medicine is called Desferrioxamine Mesilate .
What is in this leaflet
What Desferrioxamine Mesilate is and what it is used for
What you need to know before you use Desferrioxamine Mesilate
How to use Desferrioxamine Mesilate
Possible side effects
How to store Desferrioxamine Mesilate
Contents of the pack and other information
What Desferrioxamine Mesilate is and what it is used for
Desferrioxamine Mesilate is an injection used to remove excess iron or aluminium from your blood.
Desferrioxamine mesilate, the active ingredient in Desferrioxamine Mesilate, is a substance called a
‘chelating’ agent. This means that it binds to the iron and aluminium ions in the blood to form a
complex which is then excreted from the body.
You may have too much iron or aluminium in your blood as a result of iron poisoning or as a side
effect of blood transfusion or kidney dialysis. Certain illnesses can also have the same effect.
Desferrioxamine Mesilate can also be used to test whether you have certain anaemias or diseases
affecting the amount of iron in your blood.
What you need to know before you use Desferrioxamine Mesilate
Do not use Desferrioxamine Mesilate:
if you are allergic to desferrioxamine or any of the other ingredients of this medicine (listed in
Warnings and precautions
Talk to your doctor, or nurse before using Desferrioxamine Mesilate:
If you are pregnant or planning to become pregnant. If you become pregnant while you are
being treated with Desferrioxamine Mesilate you must tell your doctor straight away.
If you are breast feeding.
If you have any kidney problems or are you on dialysis?
If you have a heart condition.
If you have the blood condition thalassaemia.
If Desferrioxamine Mesilate is going to be given to a child under the age of 3 years. If it is, the
doctor may want to monitor the child’s growth regularly to make sure it is not being affected by
the Desferrioxamine Mesilate.
If your doctor has told you that you have hyperparathyroidism (a condition resulting in excess
calcium in the blood and problems with the bones).
If your doctor has told you that aluminium has affected your nerves. If so you may be given a
dose of clonazepam before you are given Desferrioxamine Mesilate.
Other warnings and precautions
Medical check-ups while you are using Desferrioxamine Mesilate
If you use Desferrioxamine Mesilate for a long time or you have kidney problems and are on dialysis,
your doctor may want to give you regular eye tests and hearing tests. This is because Desferrioxamine
Mesilate can affect your vision and your hearing. These tests are usually done every 3 months.
In children under the age of 3 years high doses of Desferrioxamine Mesilate may affect growth.
Regular checks on body weight and height are, therefore recommended in children using
Desferrioxamine Mesilate. These checks are usually done every 3 months.
X-rays or scans
The results may be affected by treatment with Desferrioxamine Mesilate. Make sure that the doctor or
nurse knows that you are being treated with Desferrioxamine Mesilate if an X-ray or scan is
Other medicines and Desferrioxamine Mesilate
Some medicines can interfere with your treatment. Tell your doctor if you are taking any of the
prochlorperazine, a medicine used to control vertigo or nausea and vomiting, anxiety or
erythropoietin (used to treat anaemia, particularly in people who are on dialysis)
Tell your doctor if you are taking, have recently taken or might take any other medicines.
This means medicines you have bought yourself as well as medicines on prescription from your
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Desferrioxamine Mesilate can make you feel dizzy or drowsy. It can also affect your vision or
hearing. You must not drive, operate machinery or do anything else which requires concentration
until you know how your medicine affects you.
How to use Desferrioxamine Mesilate
The doctor will have decided what dose of Desferrioxamine Mesilate you need and when you should
receive it. The dose will be on the pharmacist’s label. Check the label carefully. Check with your
doctor or nurse if you are not sure.
A doctor or nurse may prepare your injection for you, or you may be taught how to do this yourself.
The Desferrioxamine Mesilate powder should be dissolved in the ‘water for injection’ that your
pharmacist has given you.
Treatment with the solution should start within 3 hours of the vial being reconstituted. If the solution
has been prepared under sterile conditions (for instance in a hospital), it may be stored at room
temperature (25 oC or below) for up to 24 hours before being used. Any unused Desferrioxamine
Mesilate injection should be thrown away.
Ways in which Desferrioxamine Mesilate can be given
Desferrioxamine Mesilate can be given in different ways, for example:
By injection into a muscle. This is called being given intramuscularly.
By injection into a vein. This is called being given intravenously. It should be given slowly
over a period of time rather than all in one go. This is called a slow infusion.
By injection under your skin. This is called being given subcutaneously. It may be given over a
period of time using a special pump. This is called an infusion.
By injection into the peritoneum (the membrane that lines the abdominal cavity and forms the
outer coating of the abdominal organs). This is called intraperitoneal administration.
The dose that you need will depend on why you have to take Desferrioxamine Mesilate. Your doctor
will work out exactly how much Desferrioxamine Mesilate you need. This is especially important if
you have low serum ferritin levels or acute iron intoxication.
The recommended doses and ways of taking Desferrioxamine Mesilate are as follows:
Iron Poisoning Treatment
To treat iron poisoning Desferrioxamine Mesilate is usually given intravenously (injected into the
vein). The recommended dose is 15 mg/kg body weight every hour. This may be reduced after 4 to
6 hours. The maximum recommended dose is 80 mg/kg body weight every 24 hours.
Desferrioxamine Mesilate may also be given intramuscularly (injected into the muscle). The
recommended dose if Desferrioxamine Mesilate is given like this is 2 g for an adult or 1 g for a child.
This is usually given in a single injection.
Iron Overload Treatment
Your doctor will work out exactly how much Desferrioxamine Mesilate you will need. This will
depend on how much extra iron you have in your body. Desferrioxamine Mesilate is usually given
subcutaneously (a slow injection under the skin). It can sometimes be given intramuscularly (injected
into the muscle) though. The recommended dose is usually between 20 and 60 mg/kg body weight. It
is usually given between 5 and 7 times a week, depending on how much extra iron you have got in
your body. In children under 3 years of age the average daily dose is not usually more than 40 mg/kg.
Aluminium Overload Treatment
Desferrioxamine Mesilate is usually given by slow intravenous injection.
The exact dose of Desferrioxamine Mesilate that you need will depend on how much extra aluminium
you have in your body. Your doctor will do tests to work this out.
If you are on dialysis, the recommended dose of Desferrioxamine Mesilate is 5 mg/kg body weight.
This is normally given once a week. When you are given Desferrioxamine Mesilate will depend on
how much extra aluminium you have in your body. It will either be given during the last 60 minutes
of your dialysis or 5 hours before your dialysis starts.
If you are on peritoneal dialysis (CAPD or CCPD), the recommended dose of Desferrioxamine
Mesilate is, again 5 mg/kg body weight. This is normally given once a week. Usually the
Desferrioxamine Mesilate is mixed with the fluid in your dialysis bag. However, it can also be given
by any of the other ways listed above.
Testing to see if you have got too much iron in your body
nurse will probably want you to collect urine samples for about 6 hours. They will then do tests on
your urine to see how much iron is in it.
Testing to see if you have got too much aluminium in your body if you are on dialysis
Your doctor or nurse will probably take a blood sample from you before you are given
Desferrioxamine Mesilate. This will be taken just before your dialysis. Tests will be done on the
blood to see how much aluminium is in it.
The recommended dose of Desferrioxamine Mesilate is 5 mg/kg body weight. It is usually given by
slow intravenous infusion (slow injection into a vein) during the last hour of dialysis.
Another blood test will probably be taken before your next session of haemodialysis to check how
much aluminium is in your blood.
Use in older patients
Desferrioxamine Mesilate is used in older patients at the same doses as for other adults.
If you take more Desferrioxamine Mesilate than you should
If you think you have either been given or have taken too much Desferrioxamine Mesilate tell your
doctor or nurse straight away. If you think you have either been given it or have taken it too often,
also tell your
doctor or nurse straight away.
If you forget to take Desferrioxamine Mesilate
If you miss one of your appointments, please let your doctor or nurse know immediately.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
Your urine may turn a reddish-brown colour. This is because there is more iron in your urine. This is
usually nothing to worry about, but if you are worried you should talk to your doctor or nurse.
Some side effects can be serious
Stop using Desferrioxamine Mesilate and tell your doctor straight away if you notice:
If you feel faint (you might have low blood pressure), have a rash, or experience itching,
tightness of chest with wheezing or coughing and difficulty in breathing (Bronchospasm) or
facial and throat swelling. These might be the result of an allergic reaction which is very rare
(likely to affect fewer than 1 in 10,000 patients).
If you notice severe decrease of urine output (sign of kidney problem) or experience
convulsion (reported mainly in patients on dialysis).Those side effects were reported with
Important information if you get an infection while you are taking Desferrioxamine Mesilate
If you start to feel feverish with a sore throat or stomach pains, or general discomfort or develop
shortness of breath while you are taking Desferrioxamine Mesilate, you must seek medical advice
This is because people who have iron or aluminium overload are more vulnerable to certain types
of infection. If you get an infection your doctor may want you to do some tests and give you
some medicines to treat the infection. You may also have to stop using Desferrioxamine Mesilate
until any infections clear up.
It is very common (may affect more than 1 in 10 people) to develop pain, swelling, redness, a rash,
scabbing at the Desferrioxamine Mesilate injection site. Less frequently blisters and a burning
be experienced. Aching muscles or joints in the arms or legs is also very common.
The side effects listed below have also been reported.
Common: may affect up to 1 in 10 people:
Headache, nausea (feeling sick) or fever
Changes in their bones, slowing down of growth (especially in children under 3).
Uncommon: may affect up to 1 in 100 people:
Vomiting, stomach pains
Problems with their ears such as tinnitus and deafness.
Rare: may affect up to 1 in 1,000 people:
Problems with their eyes such as blurred vision, impaired or loss of vision, not being able to see
colours as well (colour blindness), not being able to see at night (night blindness), blind spots,
changes in the retina, cataracts (cloudy lenses), cloudiness on the front of the eye (or cornea)
Low blood pressure (light headedness, dizziness, faintness). This can happen if Desferrioxamine
Mesilate is not given correctly.
Increased risk of getting certain infections.
Very rare: may affect up to 1 in 10,000 people:
Skin rash covering most of the body
A serious condition which causes severe breathing problems called Acute Respiratory Distress
Changes in the blood which can make you look pale or cause tiredness, headaches, nosebleeds,
dizziness or being short of breath when exercising. You might also get more frequent viral infections
(fever, chills, sore throat or mouth ulcers), or find that you bleed or bruise more easily than normal.
Stomach and gut infections.
Other effects such as dizziness, loss of feeling in their hands, feet, arms or legs, numbness or tingling
(pins and needles).
In patients on dialysis: personality changes, headache, confusion, paralysis of part or all of the body,
stiff neck, abnormal speech and eye movements.
Not known: frequency cannot be estimated from the available data.
Abnormal liver or renal function test results
If any of the symptoms become troublesome or if you notice anything else not mentioned here,
please go and see your doctor or check with your pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme,
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more
information on the safety of this medicine.
How to store
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and on the label of the
glass container (vial) after (EXP). If your doctor tells you to stop using Desferrioxamine Mesilate, ask
your pharmacist how to throw away medicines you no longer use. Do not throw away any medicines
via wastewater or household waste. These measures will help protect the environment.
Vial: Store below 25° C.
Each vial is for single use only.
After dilution: Do not refrigerate or freeze.
From a microbiological point of view, the product should be used immediately. If not used
immediately, in-use storage times and conditions prior to use are the responsibility of the user and
would normally not be longer than 24 hours at 25°C.
Do not use the solution if it is not clear, not free of particles or there has been a colour change.
Contents of the pack and other information
What Desferrioxamine Mesilate contains
The active substance is desferrioxamine mesilate. There are no other ingredients in your medicine.
What Desferrioxamine Mesilate looks like and contents of the pack
Desferrioxamine Mesilate is a white or off-white powder for solution for injection or infusion. This
means that a liquid must be added to make a solution, before it can be given to you as an injection. In
some cases, more liquid may be added to make a weaker solution which can be given to you as an
Normally, your doctor or nurse will prepare your medicine before it is given to you.
Each pack contains 10 vials (glass containers) of Desferrioxamine Mesilate 500 mg or 1, 5, 10 and 50
vials of Desferrioxamine Mesilate 2 g. Not all pack sizes may be available.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Noridem Enterprises Ltd., Evagorou & Makariou, Mitsi Building
3, Office 115, 1065 Nicosia, Cyprus.
Manufacturer: DEMO S.A., 21st km National Road Athens-Lamia, 14568 Krioneri, Athens, Greece.
This medicinal product is authorised in the Member States of the EEA under the following
UK: Desferrioxamine Mesilate 500 mg & 2g Powder for Solution for Injection or Infusion
DE: Deferoxamin 500 mg & 2 g Pulver zur Herstellung einer Injektions- oder Infusionslösung
IT: Deferoxamina Noridem 500 mg & 2g Polvere per soluzione iniettabile o infusione
CY: Deferoxamine Noridem 500mg & 2g Κόνις για ενέσιμο διάλυμα ή διάλυμα για έγχυση
EL: Deferoxamine Noridem 500mg & 2g Κόνις για ενέσιμο διάλυμα ή διάλυμα για έγχυση
This leaflet was revised in 02/2017.
If this leaflet is difficult to see or read please contact the following address
Athlone Laboratories, Ballymurray, Co. Roscommon, Ireland.
Tel: +353-9066-61109, Email: firstname.lastname@example.org.
------------------------------------------------------------------------------------------------------------------------The following information is intended for healthcare professionals only:
Special precautions for storage and disposal and other handling
Vial: Store below 25oC.
Reconstituted solution: Single use only.
The product should be used immediately after reconstitution (commencement of treatment within 3
hours). When prepared under validated aseptic conditions the reconstituted solution may be stored for a
maximum of 24 hours at room temperature (25 oC or below) before administration. If not used
immediately, in-use storage times and conditions prior to administration are the responsibility of the
user. Unused solution should be discarded.
The reconstituted solution should be clear. Do not use if particles are present. Desferrioxamine
Mesilate should preferably be employed in the form of a 10% aqueous solution, by dissolving the
contents of one 500 mg vial in 5mL of Water for injections or 2g vial in 20 mL of Water for
Treatment for chronic iron overload, e.g.
transfusional haemosiderosis in patients receiving regular transfusions e.g. thalassaemia major
primary and secondary haemochromatosis in patients in whom concomitant disorders (e.g. severe
anaemia, hypoproteinaemia, renal or cardiac failure) preclude phlebotomy.
Treatment for acute iron poisoning.
For the diagnosis of iron storage disease and certain anaemias.
Aluminium overload - In patients on maintenance dialysis for end stage renal failure where preventative
measures (e.g. reverse osmosis) have failed and with proven aluminium-related bone disease and/or
anaemia, dialysis encephalopathy; and for diagnosis of aluminium overload.
Posology and method of administration
Method of administration
Desferrioxamine Mesilate may be administered parenterally (intramuscularly, intravenously, or
For parenteral administration:
The medicinal product should preferably be employed in the form of a 10% solution, e.g. 500 mg: by
dissolving the contents of one 500mg vial in 5mL of water for injection or 2 g: by dissolving the
contents of one 2 g vial in 20 mL of water for injection. When administered subcutaneously the needle
should not be inserted too close to the dermis. The 10% Desferrioxamine Mesilate solution can be
diluted with routinely employed infusion solutions (Sodium Chloride 0.9% Infusion, Dextrose 5%
Infusion, combination of Sodium Chloride 0.9% and Dextrose 5% Infusion solutions, Ringer’s Lactate),
although these should not be used as solvent for the dry substance. Dissolved Desferrioxamine Mesilate
can also be added to dialysis fluid and given intraperitoneally to patients on continuous ambulatory
peritoneal dialysis (CAPD) or continuous cyclic peritoneal dialysis (CCPD).
Only clear pale yellow Desferrioxamine Mesilate solutions should be used. Opaque, cloudy or
discoloured solutions should be discarded. Heparin is pharmaceutically incompatible with
Desferrioxamine Mesilate solutions.
1) Treatment of acute iron poisoning
Adults and children:
Desferrioxamine Mesilate may be administered parenterally. Desferrioxamine Mesilate is an adjunct to
standard measures generally used in treating acute iron poisoning. It is important to initiate treatment as
soon as possible.
Parenteral Desferrioxamine Mesilate treatment should be considered in any of the following situations:
• all symptomatic patients exhibiting more than transient minor symptoms (e.g. more than one episode of
emesis or passage of one soft stool),
• patients with evidence of lethargy, significant abdominal pain, hypovolaemia, or acidosis,
• patients with positive abdominal radiograph results demonstrating multiple radio-opacities (the great
majority of these patients will go on to develop symptomatic iron poisoning),
• any symptomatic patient with a serum iron level greater than 300 to 350 micro g/dL regardless of the
total iron binding capacity (TIBC). It has also been suggested that a conservative approach without
Desferrioxamine Mesilate therapy or challenge should be considered when serum iron levels are in the
300 to 500 micro g/dL range in asymptomatic patients, as well as in those with self-limited, non-bloody
emesis or diarrhoea without other symptoms.
The dosage and route of administration should be adapted to the severity of the poisoning.
Dose and method of administration
The continuous intravenous administration of Desferrioxamine Mesilate is the preferred route and the
recommended rate for infusion is 15 mg/kg per hour and should be reduced as soon as the situation
permits, usually after 4 to 6 hours so that the total intravenous dose does not exceed a recommended 80
mg/kg in any 24 hour period.
However, if the option to infuse intravenously is not available and if the intramuscular route is used the
normal dosage is 2 g for an adult and 1 g for a child, administered as a single intramuscular dose.
The decision to discontinue Desferrioxamine Mesilate therapy must be a clinical decision; however, the
following suggested criteria are believed to represent appropriate requirements for the cessation of
Desferrioxamine Mesilate. Chelation therapy should be continued until all of the following criteria are
• the patient must be free of signs and symptoms of systemic iron poisoning (e.g. no acidosis, no
• ideally, a corrected serum iron level should be normal or low (when iron level falls below 100 micro
g/dL). Given that laboratories cannot measure serum iron concentrations accurately in the presence of
Desferrioxamine Mesilate, it is acceptable to discontinue Desferrioxamine Mesilate when all other
criteria are met if the measured serum iron concentration is not elevated.
• Repeat abdominal radiograph test should be obtained in patients who initially demonstrated multiple
radio-opacities to ensure they have disappeared before Desferrioxamine Mesilate is discontinued
because they serve as a marker for continued iron absorption,
• If the patient initially developed vin-rose coloured urine with Desferrioxamine Mesilate therapy, it
seems reasonable that urine colour should return to normal before halting Desferrioxamine Mesilate
(absence of vin-rose urine is not sufficient by itself to indicate discontinuation of Desferrioxamine
The effectiveness of treatment is dependent on an adequate urine output in order that the iron complex
(ferrioxamine) is excreted from the body. Therefore if oliguria or anuria develop, peritoneal dialysis or
haemodialysis may become necessary to remove ferrioxamine.
It should be noted that the serum iron level may rise sharply when the iron is released from the tissues.
Theoretically 100 mg Desferrioxamine Mesilate can chelate 8.5 mg of ferric iron.
2) Chronic Iron Overload
The main aim of therapy in well-controlled patients is to maintain an iron balance and prevent
haemosiderosis, whilst in overloaded patients a negative iron balance is desirable in order to deplete the
increased iron stores and to prevent the toxic effects of iron.
Adults and children
Desferrioxamine Mesilate therapy should be commenced after the first 10- 20 blood transfusions, or
when there is evidence from clinical monitoring that chronic iron overload is present (e.g. serum ferritin
>1000 ng/mL). The dose and mode of administration should be individually adapted according to the
degree of iron overload.
Growth retardation may result from iron overload or excessive Desferrioxamine Mesilate doses. If
chelation is started before 3 years of age growth must be monitored carefully and the mean daily dose
should not exceed 40mg/kg (see section 4.4 Special warnings and precautions for use).
The lowest effective dose should be used. The average daily dose will probably lie between 20 and 60
mg/kg/day. Patients with serum ferritin levels of < 2000 ng/mL should require about 25 mg/kg/day, and
those with levels between 2000 and 3000 ng/mL about 35 mg/kg/day. Higher doses should only be
employed if the benefit for the patient outweighs the risk of unwanted effects.
Patients with higher serum ferritin may require up to 55 mg/kg/day. It is inadvisable to regularly exceed
an average daily dose of 50 mg/kg/day except when very intensive chelation is needed in patients who
have completed growth. If ferritin values fall below 1000 ng/mL, the risk of Desferrioxamine Mesilate
toxicity increases; it is important to monitor these patients particularly carefully and perhaps to consider
lowering the total weekly dose.
To assess the chelation therapy, 24 hour urinary iron excretion should initially be monitored daily.
Starting with a dose of 500 mg daily the dose should be raised until a plateau of iron excretion is
reached. Once the appropriate dose has been established, urinary iron excretion rates can be assessed at
intervals of a few weeks.
Alternatively the mean daily dose may be adjusted based on ferritin level in order to keep the therapeutic
index below 0.025 (i.e. the mean daily dose (mg/kg) of Desferrioxamine Mesilate divided by the serum
ferritin level (micro g/L) should be below 0.025). The therapeutic index is a valuable tool in protecting
the patient from excess chelation, but it is not a substitute for careful clinical monitoring.
Method of administration
Slow subcutaneous infusion using a portable, light-weight, infusion pump over a period of 8-12 hours is
effective and particularly convenient for ambulant patients. It may be possible to achieve a further
increase in iron excretion by infusing the same daily dose over a 24 hour period. Desferrioxamine
Mesilate should normally be used with the pump 5-7 times a week. Desferrioxamine Mesilate is not
formulated to support subcutaneous bolus injection.
Since the subcutaneous infusions are more effective, intramuscular injections are given only when
subcutaneous infusions are not feasible.
Clinical studies of desferrioxamine did not include sufficient numbers of subjects aged 65 years and
over to determine whether they respond differently compared to younger subjects. In general, dose
selection for an elderly patient should be cautious, usually starting at the low end of the dosing range,
reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant
disease or other medicinal product therapy' (see sections 4.4 Special warnings and precautions for use
and 4.8 Undesirable effects).
No studies have been performed in patients with hepatic impairment.
Intravenous infusion during blood transfusion
The availability of an intravenous line during blood transfusions makes it possible to administer an
intravenous infusion, e.g. in patients who comply poorly with and/or do not tolerate subcutaneous
The Desferrioxamine Mesilate solution should not be put directly into the blood bag but may be added to
the blood line by means of a “Y” adaptor located near to venous site of injection. The patient’s pump
should be used to administer Desferrioxamine Mesilate as usual. Because of the limited amount of
medicinal product that can be administered by IV infusion during blood transfusion, the clinical benefit
of this mode of administration is limited. Patients and nurses should be warned against accelerating the
infusion, as an intravenous bolus of Desferrioxamine Mesilate may lead to flushing, hypotension and
acute collapse (see section 4.4 Special warnings and precautions for use).
Continuous intravenous infusion is recommended for patients incapable of continuing subcutaneous
infusions and in those who have cardiac problems secondary to iron overload. 24 hour urinary iron
excretion should be measured regularly where intensive chelation (IV) is required, and the dose adjusted
accordingly. Implanted intravenous systems can be used when intensive chelation is carried out.
Care should be taken when flushing the line to avoid sudden infusion of residual Desferrioxamine
Mesilate which may be present in the dead space of the line, as this may lead to flushing; hypotension
and circulatory collapse (see section 4.4 Special warnings and precautions for use).
3) Diagnosis of iron storage disease and certain anaemias
The Desferrioxamine Mesilate test for iron overload is based on the principle that normal subjects do not
excrete more than a fraction of a milligram of iron in their urine daily, and that a standard intramuscular
injection of 500 mg of Desferrioxamine Mesilate will not increase this above 1 mg of iron (18 micro
mol). In iron storage diseases, however, the increase may be well over 1.5 mg (27 micro mol). It should
be borne in mind that the test only yields reliable results when renal function is normal.
Desferrioxamine Mesilate is administered as 500 mg intramuscular injection. Urine is then collected for
a period of 6 hours and its iron content determined.
Excretion of 1-1.5 mg (18-27 micro mol) of iron during this 6-hour period is suggestive of iron
overload; values greater than 1.5 mg (27 micro mol) can be regarded as pathological.
4) Treatment for aluminium overload in patients with end stage renal failure
Patients should receive Desferrioxamine Mesilate if:
they have symptoms or evidence of organ impairment due to aluminium overload
they are asymptomatic but their serum aluminium levels are consistently above 60 ng/mL and
associated with a positive Desferrioxamine Mesilate test (see below), particularly if a bone biopsy
provides evidence of aluminium related bone disease.
The iron and aluminium complexes of Desferrioxamine Mesilate are dialysable. In patients with renal
failure their elimination will be increased by dialysis.
Adults and children
Patients on maintenance haemodialysis or haemofiltration:
5 mg/kg once a week. Patients with post-desferrioxamine test serum aluminium levels up to 300 ng/mL:
Desferrioxamine Mesilate should be given as a slow IV infusion during the last 60 minutes of a dialysis
session (to reduce loss of free active substance in the dialysate). Patients with a post-desferrioxamine test
serum aluminium value above 300 ng/mL: Desferrioxamine Mesilate should be administered by slow IV
infusion 5 hours prior to the dialysis session.
Four weeks after the completion of a three month course of Desferrioxamine Mesilate treatment a
Desferrioxamine Mesilate infusion test should be performed, followed by a second test 1 month later.
Serum aluminium increases of less than 50ng/mL above baseline measured in 2 successive infusion tests
indicate that further Desferrioxamine Mesilate treatment is not necessary.
Patients on CAPD or CCPD
5 mg/kg once a week prior to the final exchange of the day. It is recommended that the intraperitoneal
route be used in these patients. However, Desferrioxamine Mesilate can also be given i.m., by slow
infusion IV or s.c.
5) Diagnosis of aluminium overload in patients with end stage renal failure
A Desferrioxamine Mesilate infusion test is recommended in patients with serum aluminium levels >
associated with serum ferritin levels >100 ng/mL.
Just before starting the haemodialysis session, a blood sample is taken to determine the baseline level
serum aluminium level.
During the last 60 minutes of the haemodialysis session a 5 mg/kg dose is given as a slow intravenous
At the start of the next haemodialysis session (i.e. 44 hours after the aforementioned Desferrioxamine
Mesilate infusion) the second blood sample is taken to determine the serum aluminium level once more.
An increase in serum aluminium above baseline of more than 150 ng/mL is suggestive of aluminium
overload. It should be noted that a negative test does not completely exclude the possibility of aluminium
Theoretically 100 mg desferrioxamine can bind 4.1 mg Al3+.
Use in the elderly
No special dosage regime is necessary but concurrent renal insufficiency should be taken into
Hypersensitivity to the active substance unless the patients can be desensitised.
Special warnings and precautions and Interactions
Desferrioxamine Mesilate should be used with caution in patients with renal impairment since the metal
complexes are excreted via the kidneys. In these patients, dialysis will increase the elimination of
chelated iron and aluminium. Isolated cases of acute renal failure have been reported (see also section
4.8 Undesirable effects). Monitoring patients for changes in renal function (e.g. increased serum
creatinine) should be considered.
Used alone desferrioxamine may exacerbate neurological impairment in patients with aluminium-related
encelphalopathy. This deterioration (manifest as seizures) is probably related to an acute increase in
brain aluminium secondary to elevated circulating levels. Pretreatment with clonazepam has been shown
to afford protection against such impairment. Also, treatment of aluminium overload may result in
decreased serum calcium and aggravation of hyperparathyroidism.
Rapid intravenous infusion
Treatment with Desferrioxamine Mesilate by the intravenous route should only be administered in the
form of slow infusions. Rapid intravenous infusion may lead to hypotension and shock (e.g. flushing,
tachycardia, circulatory collapse and urticaria).
Instructions for use and handling
Desferrioxamine Mesilate should not be administered s.c. in concentrations and/or doses higher than
those recommended as local irritation at the site of administration may occur more frequently.
Patients suffering from iron overload are particularly susceptible to infection. There have been reports of
desferrioxamine promoting some infections such as Yersinia enterocolitica and Y. pseudotuberculosis. If
patients develop fever with pharyngitis, diffuse abdominal pain or enteritis/enterocolitis,
Desferrioxamine Mesilate therapy should be stopped, and appropriate treatment with antibiotics should
be instituted. Desferrioxamine Mesilate therapy may be resumed once the infection has cleared.
In patients, receiving desferrioxamine for aluminium and/or iron overload there have been rare reports
of mucormycosis (a severe fungal infection), some with fatal outcome. If any characteristic signs or
symptoms occur desferrioxamine treatment should be discontinued, mycological tests carried out and
appropriate treatment immediately instituted. Mucormycosis has been reported to occur in dialysis
patients not receiving desferrioxamine, thus no causal link with the use of the medicinal product has
Visual and hearing impairment
Disturbances of vision and hearing have been reported during prolonged desferrioxamine therapy. In
particular, this has occurred in patients on higher than recommended therapy or in patients with low
serum ferritin levels. Patients with renal failure who are receiving maintenance dialysis and have low
ferritin levels may be particularly prone to adverse reactions, visual symptoms having been reported after
single doses of desferrioxamine. Therefore, ophthalmological and audiological tests should be carried
out both prior to the institution of therapy with Desferrioxamine Mesilate and at 3-monthly intervals
during treatment particularly if ferritin levels are low. By keeping the ratio of the mean daily dose
(mg/kg of Desferrioxamine Mesilate) divided by the serum ferritin (micro g/L) below 0.025 the risk of
audiometric abnormalities may be reduced in thalassaemia patients. A detailed ophthalmological
assessment is recommended (visual field measurements, fundoscopy, and colour vision testing using
pseudoisochromatic plates and the Farnsworth D-15 colour test, slit lamp investigation, visual evoked
If disturbances of vision or hearing do occur, treatment with Desferrioxamine Mesilate should be
stopped. Such disturbances are usually reversible. If Desferrioxamine Mesilate therapy is re-instituted
later at a lower dosage, close monitoring of ophthalmological/auditory function should be carried out
with due regard to the risk-benefit ratio.
Paediatric population: growth retardation
The use of inappropriately high doses of desferrioxamine in patients with low ferritin levels or young
children (<3 years at commencement of treatment) has also been associated with growth retardation;
dose reduction has been found to restore the growth rate to pretreatment levels in some cases. Three
monthly checks on body weight and height are recommended in children. Growth retardation if
associated with excessive doses of desferrioxamine must be distinguished from growth retardation from
Growth retardation from desferrioxamine use is rare if the dose is kept below 40 mg/kg; if growth
retardation has been associated with doses above this value, then reduction of the dose may result in
return in growth velocity, however, predicted adult height is not attained.
Acute respiratory distress syndrome
Acute respiratory distress syndrome has been described following treatment with excessively high IV
doses of desferrioxamine in patients with acute iron intoxication, and also in thalassaemic patients (see
section 4.8 Undesirable effects). The recommended daily doses should therefore not be exceeded.
It should be noted that desferrioxamine will affect aluminium levels and may necessitate some
dosage adjustment of erythropoietin if co-prescribed.
Interaction with other medicinal products and other forms of interaction
Oral administration of vitamin C (up to a maximum of 200 mg daily, given in divided doses) may serve
to enhance excretion of the iron complex in response to desferrioxamine; larger doses of vitamin C fail
to produce an additional effect. Monitoring of cardiac function is indicated during such combined
therapy. Vitamin C should be given only if the patient is receiving desferrioxamine regularly and should
not be administered within the first month of desferrioxamine therapy.
In patients with severe chronic iron-storage disease undergoing combined treatment with
desferrioxamine and high doses of vitamin C (more than 500 mg daily) impairment of cardiac function
has been encountered; this proved reversible when the vitamin C was withdrawn. Vitamin C
supplements should not, therefore, be given to patients with cardiac failure.
Desferrioxamine Mesilate should not be used in combination with prochlorperazine (a phenothiazine
derivative) since prolonged unconsciousness may result.
Gallium67 imaging results may be distorted because of the rapid urinary excretion of desferrioxamine
bound radiolabel. Discontinuation of desferrioxamine 48 hours prior to scintigraphy is advised.
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